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Pediatric Development: Can Increasing Collaboration Lead to Fewer Unnecessary Trials?
Session Chair(s)
Max Wegner, PharmD
Senior Vice President,Head Regulatory Affairs, Bayer, Germany
An evolving regulatory framework supports and incentivizes pediatric drug development. This session compares recent experience in the US, EU, China, and Canada and explores options for advancing global approaches.
Learning Objective : Discuss the evolving global regulatory framework for development of pediatric medicines in the US, EU, China, and Canada; Describe common challenges and opportunities faced with global planning and conduct of pediatric programs; Review case studies illustrating a global approach for development of pediatric medicines.
Speaker(s)
Alysha Croker, PhD
Director, Strategic and Horizontal Policy, Health Canada, Canada
Health Canada Perspectives
Lynne Yao, MD
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Can Increasing Collaboration Lead to Fewer Unnecessary Clinical Trials? FDA Perspectives
Zhimin Yang, MD
Deputy Director, Center for Drug Evaluation, National Medical Products Administration (NMPA), China
Considerations on Promoting Pediatric Clinical Trials in China: Perspective from Agency
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